ALBERT

Description: Introduction: Chimeric antigen receptor T (CAR-T) cell therapies targeting CD19 antigen can yield durable remissions in relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL). Yet the use of CAR-T can be limited by potentially severe toxicities, principally cytokine release syndrome (CRS) and neurologic toxicities. Management of neurologic toxicities requires vigilant monitoring, supportive treatment and resource allocation. We found no studies reporting healthcare costs associated with treatment-related neurologic adverse events (NEAEs) in r/r DLBCL patients. The objective of this study was to develop an evidence-based list of r/r DLBCL treatment-related NEAEs and to estimate the healthcare costs associated with these NEAEs in a real-world setting. Methods: Grade 3 or higher NEAEs that occurred in ≥2% of patients were identified by reviewing U.S. drug prescribing information (PI), European Medicines Agency summaries of product characteristics, and published clinical trials for treatments of r/r DLBCL. Then, adult patients ≥18 years old with r/r DLBCL were identified from a U.S. administrative claims database containing de-identified claims for over 150 million people across over 11 years. Patients were included if they had: 1) evidence of treatment beyond first-line (2L+) during the identification period (07/01/14 - 12/31/18); and 2) ≥1 inpatient or ≥2 outpatient claims for DLBCL (ICD-9-CM codes: 200.7X; ICD-10-CM codes: C83.3X) during the study period (01/01/14 - 12/31/18) with ≥1 having occurred prior to or on the date when the 2L+ treatment was received. 2L+ treatments were selected based on National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines and clinical expert input. To maximize the identification of patients treated with CAR-T, treatments were categorized hierarchically into 4 groups: CAR-T therapy (axicabtagene ciloleucel, or tisagenlecleucel), high-intensity cytotoxic therapy (carboplatin, cisplatin, cyclophosphamide, or ifosfamide), low-intensity cytotoxic therapy (bendamustine, lenalidomide, or gemcitabine), and targeted monotherapy (rituximab, ibrutinib, or brentuximab vedotin). The index date was defined as the start date of the 2L+ treatment. Patients in the cytotoxic and targeted therapy groups were also required to have evidence of an earlier line of cytotoxic or targeted therapy. All patients were required to have ≥6-months continuous enrollment before the index date. The outcomes of interest were the rates of NEAEs and total healthcare costs for patients with and without NEAEs during the 30-day post index period. Costs were inflated to 2018 US dollars. Descriptive statistics were reported. Results: Twenty-three NEAEs were identified based on the review: 17 for CAR-T, 10 for conventional immunochemotherapy regimens, and 4 for both. In the claims database, a total of 349 adult patients with r/r DLBCL were identified, including 27 CAR-T therapy, 262 high-intensity cytotoxic therapy, 50 low-intensity cytotoxic therapy, and 10 targeted therapy users. Mean (median, SD) patient age was 72.3 (73; 10.3) years, with 47.9% being female and 83.4% having Medicare insurance. Patients were mainly from the South (44.1%) and the Midwest (31.5%). The mean (SD) Charlson comorbidity index was 4.4 (3.6) and mean (SD) number of chronic conditions was 7.3 (2.2). Forty-five (12.9%) patients had ≥1 NEAE at some point during the 30-day post-index period. Of these, 14 (31.1%) were CAR-T users. Eleven (40.7%) of the CAR-T users had encephalopathy. Mean total healthcare costs were $99,611 higher for patients with NEAEs [mean (SD): $153,435 (227,771)] than those without any NEAEs [$53,824 (96,170)]. Among patients with NEAEs, 72% of the healthcare costs were accrued in the inpatient setting. Among patients without NEAEs, 63% of the healthcare costs were for outpatient medical services. The trend of higher costs in patients with NEAEs was consistent across treatment groups. Conclusion: This is the first study of the economic burden of NEAEs associated with treating r/r DLBCL in a real-world setting with data that reflects the current range of treatment options. Patients with r/r DLBCL who have NEAEs incur substantially higher costs than those without such events. In this analysis, CAR-T is overrepresented for NEAEs, although the sample size is small. We intend to repeat the analysis when more claims data becomes available in the near future. Disclosures Broder: Partnership for Health Analytic Research (PHAR), LLC: Other: I am an employee of the Partnership for Health Analytic Research (PHAR), LLC, which was paid by Novartis to conduct the research described in this abstract.. Ma:Novartis Pharmaceuticals Corporation: Employment. Yan:Partnership for Health Analytic Research (PHAR), LLC: Other: T. Yan is an employee of Partnership for Health Analytic Research (PHAR), LLC, a health services research company paid to conduct this research.. Chang:Partnership for Health Analytic Research (PHAR), LLC: Other: E. Chang is an employee of Partnership for Health Analytic Research (PHAR), LLC, a health services research company paid to conduct this research.. Eldjerou:Novartis Pharmaceuticals Corporation: Employment. Hao:Novartis Pharmaceuticals Corporation: Employment, Equity Ownership. Kuzan:Novartis Pharmaceuticals Corporation: Employment. Zhang:Novartis Pharmaceuticals Corporation: Employment, Equity Ownership.

Description: Background: Patients with myelodysplastic syndrome (MDS) may present with anemia and become red blood cell (RBC) transfusion dependent (TD), which increases the risk of iron overload (IO). Iron chelation therapy (ICT) treats IO and has been shown to be associated with improved survival and quality of life among TD MDS patients. Deferasirox (DFX) is an oral ICT used to reduce IO in TD MDS patients. This study aims to assess real-world treatment patterns and adherence among MDS patients on Medicare receiving DFX as ICT. Methods: This was a retrospective cohort study using 100% Medicare claims data from 2006-2013. Patients were diagnosed with MDS, identified using ICD-9 codes (238.72-238.76), and entered the study cohort when they met a minimum transfusion threshold of either: 10 consecutive weeks with at least 1 unit of RBC transfusion, or 20 total units of RBC transfusions. Treatment patterns, including discontinuation and treatment changes, were assessed among patients who received DFX as initial ICT and who had ≥180 days of follow-up. Discontinuation was defined as a minimum 45-day treatment gap. Adherence was defined as a medication possession ratio (MPR) ≥ 0.8. Treatment discontinuation, overall survival, acute myeloid leukemia (AML)-free survival, and cardiac event-free survival were compared between adherent and non-adherent patients using Kaplan Meier (KM) survival analysis, as well as Cox regressions controlling for time-dependent ICT use and baseline characteristics. Survivals were estimated as time from cohort entry to the event. Results: Among 6,796 MDS patients who met the minimum transfusion threshold, 591 (8.7%) received ICT. Median weeks of ICT was 15.14 (range=2.29 - 201.43 weeks). 583 (98.6%) initiated with DFX, and 374 DFX patients had a follow-up period of ≥180 days. Of these 374 patients, 213 (57.0%) discontinued DFX treatment within 180 days of initiation. Among the remaining 161 patients, one switched to deferoxamine (DFO), none augmented treatment with DFO, and 160 continued on DFX. The KM-estimated 3-month and 1-year DFX discontinuation rates were 36.5% and 77.4%, respectively, and the average time to discontinuation was 84.4 [Standard Deviation [SD]=48.6] days. Overall, the average 6-month MPR was 0.69 (SD=0.30), and 49.1% of patients were adherent (MPR≥0.8). Adherent patients had similar baseline characteristics compared with non-adherent patients, except that a lower proportion had renal disease (24.2% vs. 38.3%, P

Description: Background: Recent literature provides conflicting views on whether there is a negative value trend in pharmaceutical oncology treatments. A previous study (J Econ Perspect 2015;29:1) found that the price of pharmaceutical oncology treatments has outpaced the improvements in survival benefits over time, with most treatments developed since 1995 offering marginal improvements in survival with significant increases in costs. In contrast, other literature suggests pharmaceutical oncology treatments have produced significant value. Chimeric antigen receptor t-cell (CAR-T) therapy represents a novel approach for treating particular hematologic cancers-including pediatric acute lymphoblastic leukemia and diffuse large b-cell lymphoma-but a remaining question is whether CAR-T represents a continued trend of low-value innovation, or a significant break from past trends. In this study, we investigate three key questions: (i) what are the trends over the past 10 to 20 years in incremental quality-adjusted life years (QALYs) and incremental cost per incremental quality-adjusted life year (cost/QALY) for newly approved anti-cancer innovations? (ii) how do innovations for hematologic cancers differ from those for other cancers in terms of this value trend? and (iii) how does CAR-T therapy compare with the recent history of innovations for both hematologic and non-hematologic cancers? Methods: We identified all analyses of pharmaceutical treatments for cancer published since 2007 that appear in the Tufts Medical Center Cost-Effectiveness Analysis (CEA) Registry, a comprehensive database focusing on a subset of CEAs called cost-utility analyses (CUAs), which quantify health benefits in terms of QALYs. CUA results on CAR-T therapies came from an analysis conducted by the Institute for Clinical and Economic Review (2018). We limited the CUAs in our study to those conducted in the US context with at least one of the following measures of value: incremental QALYs or cost/QALY, and with intervention/indication approval year 1995 or later. We measured linear trend in the value measures as a function of approval year and compared interventions for non-hematologic cancers with non-CAR-T interventions for hematologic cancers and, in turn, with CAR-T therapy. Regression analysis was used to control for the potential influence of characteristics of a CUA such as discount rate chosen, time horizon, number of years between publication and approval of the intervention for the indication in question, and an indicator for rare diseases as defined by the Genetic and Rare Diseases Information Center of the NIH. Indicators for CAR-T therapy and for non-CAR-T treatments for hematologic cancers were included to test for differences from innovations for other cancer types. Results: 103 incremental QALY and 108 cost/QALY measures met our inclusion criteria. The figures show incremental QALYs and cost/QALY, respectively, by approval year. The regression analysis shows that -- for innovations as a whole -- incremental QALYs gained have declined with approval year by 0.079 per year (95% CI -0.128 to -0.030). Cost effectiveness has worsened somewhat over time although that trend is not statistically significant (cost/QALY increase of $36,147 per year, 95%CI -$29,575 to $101,868). CAR-T is substantially more effective than both pharmaceutical cancer innovations outside of hematology (5.17 more incremental QALYs, 95%CI 4.09 to 6.25) and other innovations within hematology (4.67 more incremental QALYs, 95%CI 3.44 to 5.90). Innovations in hematology other than CAR-T are somewhat more effective than innovations outside of hematology (0.5 more incremental QALYs, 95%CI -0.09 to 1.09), although the difference is not statistically significant. Differences in cost/QALY between CAR-T and other pharmaceutical interventions are not statistically significant. Conclusions: CAR-T therapy improved health outcomes (measured in QALYs) to a greater extent than both treatments for non-hematologic cancers and non-CAR-T treatments for hematologic cancers, with no significant differences in cost/QALY. Those improvements represent a break from a trend previously reported in the literature of negligible incremental effectiveness and rising costs per life-year gained. Disclosures Baumgardner: Precision Health Economics: Employment. Everson:Precision Health Economics: Employment. Brauer:Precision Health Economics: Employment. Zhang:Novartis Pharmaceuticals Corporation: Employment, Equity Ownership. Hao:Novartis Pharmaceuticals Corporation: Employment, Equity Ownership. Liu:Novartis Pharmaceuticals Corporation: Employment, Equity Ownership. Lakdawalla:Precision Health Economics: Consultancy; Novartis Pharmaceuticals Corporation: Other: PHE conducted the research underlying this study with funding from Novartis.; Precision Medicine Group: Equity Ownership.

Description: INTRODUCTION: Acute lymphoblastic leukemia (ALL) is a hematological malignancy that primarily affects children, adolescents, and young adults. Patients with refractory disease or in second or later relapse have a poor prognosis and are less likely to achieve long-term disease remission. In August 2017, tisagenlecleucel, a Chimeric antigen receptor T-cell (CAR-T) therapy, received approval from the US Food and Drug Administration (FDA) for the treatment of pediatric and young adult patients with B-cell ALL that is refractory or in second or later relapse based on data from the pivotal Phase II trial ELIANA. Since the launch of tisagenlecleucel in ALL, there has been discussion on the expected health resource use (HRU) and costs associated with the treatment beyond the cost of the drug and procedure. The current study aimed to estimate the total costs of tisagenlecleucel for the treatment of pediatric and young adult patients with relapsed or refractory (r/r) ALL from a US hospital's perspective using the HRU and safety data from the ELIANA trial. METHODS: An economic model was developed to assess the total costs associated with tisagenlecleucel treatment among pediatric and young patients with r/r ALL from a US hospital's perspective. The total costs were estimated from the time of leukapheresis to 2 months post-infusion, which is the timeframe when HRU related to the tisagenlecleucel infusion would likely occur. The model was developed using a fee-for-service approach, which estimated costs based on the HRU and safety data from the ELIANA trial. The model considered costs of leukapheresis, lymphodepleting chemotherapy, tisagenlecleucel infusion and hospital administration, inpatient and intensive care unit (ICU) admission, medical professional visits, lab tests and procedures, and additional medication and HRU for the management of major adverse events (AEs) (e.g., cytokine release syndrome [CRS]). Medication costs were estimated using the wholesale acquisition cost from the Truven Redbook. Unit costs for medication administration, medical professional visits, and lab test and procedures were obtained from the Centers for Medicare & Medicaid Services Physician Fee Schedule. Unit costs for AE were derived from the Healthcare Cost and Utilization Project. The daily inpatient and ICU costs were obtained from the literature. All costs were inflation-adjusted to 2019 USD. The base-case model estimated the total costs using the observed hospitalization, ICU and AE data from all patients receiving tisagenlecleucel infusion in the ELIANA trial. Scenario analyses were conducted varying key assumptions related to AEs and hospitalization. RESULTS: The overall costs associated with the tisagenlecleucel treatment from leukapheresis to 2-months post infusion in r/r ALL patients were estimated at $612,779. Considering a list price of tisagenlecleucel at $475,000, the model calculated additional cost of care to be $137,636, which included $70,968 (51.5%) for AE management, $57,952 (42.1%) for inpatient and ICU not attributing to AEs, $5,209 (3.8%) for lab tests and procedures, $1,780 (1.3%) for medical professional visits, and $1,727 (1.3%) for lymphodepleting drug and administration. In the sensitivity analyses, the total costs ranged from $483,169 (no AEs, no hospitalization) to $672,373 (CRS and other AEs, hospitalization). CONCLUSIONS: This is the first US-focused study that comprehensively evaluated the cost associated with tisagenlecleucel treatment based on HRU data from clinical trial observation. The total costs within 2 months of tisagenlecleucel administration was estimated at $612,779, on average. Compared to the cost of tisagenlecleucel procedure, the non-drug cost is relatively small. Further research with estimates based on real-world clinical use of tisagenlecleucel is warranted. Disclosures Yang: Astellas: Other: I am an employee of Analysis Group, Inc., which provided paid consulting services to Astellas for the conduct of this study; Analysis Group, Inc.: Employment. Hao:Novartis Pharmaceuticals Corporation: Employment, Equity Ownership. Qi:Astellas: Other: I am an employee of Analysis Group, Inc., which provided paid consulting services to Astellas for the conduct of this study; Analysis Group, Inc.: Employment. Chai:Analysis Group, Inc.: Employment; Novartis: Other: I am an employee of Analysis Group, Inc., which provided paid consulting services to Novartis for the conduct of this study. Wu:Novartis: Other: I am an employee of Analysis Group, Inc., which provided paid consulting services to Novartis for the conduct of this study.

Description: INTRODUCTION: Diffuse large b-cell lymphoma (DLBCL) is a common and aggressive form of non-Hodgkin lymphoma (NHL). Relapsed/refractory (r/r) patients after two lines of therapy have limited treatment options and poor prognosis. In August 2018, tisagenlecleucel, a chimeric antigen receptor T-cell (CAR-T) therapy, received approval from the US Food and Drug Administration (FDA) for the treatment of r/r DLBCL after two or more lines of systemic therapy. Given the novel mechanism of action of tisagenlecleucel, there has been a need to understand the health resource use (HRU) and costs associated with such treatment. The current study aimed to estimate the total costs associated with tisagenlecleucel treatment in adult patients with r/r DLBCL from a US hospital's perspective. METHODS: An economic model was developed to assess the total costs associated with tisagenlecleucel treatment among adult patients with r/r DLBCL from a US hospital's perspective. The total costs were estimated from the time of leukapheresis to 2 months post-infusion, which is the timeframe when HRU related to the tisagenlecleucel infusion would likely occur. The model was developed using a fee-for-service approach, which estimated costs based on the HRU and safety data from the pivotal Phase 2 JULIET trial. The model considered costs of leukapheresis, lymphodepleting chemotherapy, tisagenlecleucel infusion and hospital administration, inpatient and intensive care unit (ICU) admission, medical professional visits, lab tests and procedures, and additional medication and HRU for the management of major adverse events (AEs) (e.g., cytokine release syndrome [CRS]). Medication costs were estimated using the wholesale acquisition cost from the Truven Redbook. Unit costs for drug administration and medical professional visits were from the Centers for Medicare & Medicaid Services Physician Fee Schedule. Unit costs for AE were derived from the Healthcare Cost and Utilization Project. Lab tests, procedure costs, and daily inpatient and ICU costs were obtained from a hospital database analysis. All costs were inflation-adjusted to 2019 USD. The base-case model estimated the total costs using the observed hospitalization, ICU, and AE data from all patients receiving tisagenlecleucel infusion in the JULIET trial. Scenario analyses were conducted varying key assumptions related to AEs and hospitalization. RESULTS: The overall cost associated with the tisagenlecleucel treatment from leukapheresis to 2-months post infusion in r/r DLBCL patients were estimated at $437,927. Considering a list price of tisagenlecleucel at $373,000, the model calculated additional cost of care to be $64,784, which included $30,594 (47.2%) for AE management, $24,285 (37.5%) for inpatient and ICU not attributing to AEs, $5,443 (8.4%) for lab tests and procedure, $3,052 (4.7%) for lymphodepleting drug and administration, and $1,410 (2.2%) for medical professional visit. In the sensitivity analyses, the total costs ranged from $382,702 (no AEs, no hospitalization) to $469,006 (CRS and other AEs, hospitalization). CONCLUSIONS: This is the first US-focused study that comprehensively evaluated the costs associated with tisagenlecleucel treatment based on HRU data from clinical trial. The total cost within 2 months of tisagenlecleucel administration was estimated at $437,927, on average. Compared to the cost of tisagenlecleucel procedure, the non-drug cost is relatively small. Further research with estimates based on real-world clinical use of tisagenlecleucel is warranted. Disclosures Yang: Astellas: Other: I am an employee of Analysis Group, Inc., which provided paid consulting services to Astellas for the conduct of this study; Analysis Group, Inc.: Employment. Hao:Novartis Pharmaceuticals Corporation: Employment, Equity Ownership. Chai:Analysis Group, Inc.: Employment; Novartis: Other: I am an employee of Analysis Group, Inc., which provided paid consulting services to Novartis for the conduct of this study. Qi:Analysis Group, Inc.: Employment; Astellas: Other: I am an employee of Analysis Group, Inc., which provided paid consulting services to Astellas for the conduct of this study. Wu:Novartis: Other: I am an employee of Analysis Group, Inc., which provided paid consulting services to Novartis for the conduct of this study.

Description: Background: The majority of patients with myelodysplastic syndromes (MDS) develop anemia, and may require red blood cell (RBC) transfusions and become transfusion-dependent. Transfusion-dependency places patients at significant risk of developing iron overload. Iron chelation therapy (ICT) has been associated with improved overall and leukemia-free survival among MDS patients with iron overload. This study aims to assess the real-world treatment patterns of ICT among MDS patients, and its associated survival outcomes. Methods: Using 100% Medicare claims data from 2006-2013, this retrospective cohort study included patients diagnosed with MDS, identified using ICD-9 codes (238.72-238.76). Selected patients entered the study cohort when they met a minimum transfusion threshold of either: 10 consecutive weeks with at least 1 unit of RBC transfusion, or 20 total units of RBC transfusions. Patients were classified into ICT and non-ICT cohorts depending on whether ICT was received after meeting the minimum transfusion threshold, and were observed until death or end of follow up in the database. Patient characteristics and clinical outcomes were compared between the ICT and non-ICT cohorts. Overall survival, acute myeloid leukemia (AML)-free survival, and cardiac event-free survival were assessed using Kaplan Meier (KM) survival analysis, as well as Cox regressions controlling for time-dependent ICT use and baseline characteristics. Survivals were estimated from time of cohort entry until the event. Results: 591 (8.7%) of the 6,796 MDS patients who met the minimum transfusion threshold received ICT. Median weeks of ICT was 15.14 (range= 2.29 - 201.43 weeks). The ICT cohort was younger (77 vs. 80 years, P

Description: Introduction: DLBCL is the most common form of non-Hodgkin's lymphoma accounting for more than 30% of the new lymphoma cases in adults in the US.First-line treatment of patients with DLBCL typically includes immunochemotherapy with or without radiation therapy. Autologous HSCT is recommended in relapsed and refractory patients with chemosensitive disease. Allogeneic HSCT, a highly specialized procedure associated with intensive medical resources and costs, is generally considered for patients with refractory disease or who relapse following autologous HSCT.The objective of this study was to describe the short-term and long-term economic burden following an allogeneic HSCT procedure for adult patients with highest risk DLBCL. Methods : Adult patients (≥18 years old) with DLBCL who underwent an allogeneic HSCT in a hospital setting were selected from two large US administrative claims databases (Q1 2006 to Q2 2015). Selected patients had continuous healthcare plan enrollment for ≥90 days prior to and ≥30 days after the date of the HSCT (index date). To characterize the short-term and long-term economic burden following allogeneic HSCT, healthcare resource utilization (HRU) and direct healthcare costs were measured and described over five study periods: 1) between the index date and the HSCT hospitalization discharge date, 2) during the first 100 days following the index date, and 3) during the first, 4) second, 5) third year following the index date. For each study period, HRU and costs were assessed among patients with continuous healthcare plan enrollment during the entire study period. Healthcare costs were measured from payers' perspective, reflecting the total amount reimbursed by the private payer and the amount covered by the coordination of benefits, excluding deductibles and copayments. Healthcare costs were adjusted for inflation and reported in 2015 USD. Results: A total of 101 adult patients with DLBCL who received an allogeneic HSCT were identified. The average age was 54 years old at the time of the index date and 62% of patients were male. The median duration of the HSCT hospitalization was 24 days. The mean follow-up period after the index date was 1.3 years. Results showed substantial HRU and costs following the allogeneic HSCT. The more intensive HRU and the highest healthcare costs were observed during the first year following the HSCT; patients had a mean of 2.5 inpatient admissions (including the hospitalization for the HSCT) for a total of 38 inpatients days and 68 days of outpatient services (apart from home care services), including 43 days with laboratory or imaging services. The mean total healthcare cost during the first year following the index date was $455,741 (median of $416,744; interquartile range from $301,344 to $575,662) - and the mean total healthcare cost during the hospitalization for the HSCT was $248,390 (median of $200,945; interquartile range from $156,908 to $281,279). Results also showed that although HRU and costs tend to decrease over time, they remain high even 3 years after the HSCT (Figure 1): during the third year following the index date, patients had a mean total healthcare cost of $72,957 (median of $76,749; interquartile range from $20,341 to $100,422), and mean of 27 days with outpatient services (apart from home care services), including 13 days with laboratory or imaging services. Conclusion: Findings from this study showed that among adult patients with DLBCL, short-term and long-term economic burden following an allogeneic HSCT procedure is substantial. Figure 1 Total healthcare cost following the allogeneic HSCT procedure Figure 1. Total healthcare cost following the allogeneic HSCT procedure Disclosures Maziarz: Incyte: Membership on an entity's Board of Directors or advisory committees; Novartis Pharmaceuticals Corporation: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Athersys: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding. Hao:Novartis Pharmaceuticals Corporation: Employment, Equity Ownership. Guerin:Analysis Group, Inc: Employment; Novartis Pharmaceuticals Corporation: Consultancy, Other: Annie Guerin is an employee of Analysis Group, which has received consultation fees from Novartis Pharmaceuticals Corporation. Gauthier:Analysis Group, Inc.: Employment; Novartis Pharmaceuticals Corporation: Consultancy, Other: Genevieve Gauthier is an employee of Analysis Group, which has received consultation fees from Novartis Pharmaceuticals Corporation. Gauthier-Loiselle:Analysis Group, Inc.: Employment; Novartis Pharmaceuticals Corporation: Other: Marjolaine Gauthier-Loiselle is an employee of Analysis Group, which has received consultation fees from Novartis Pharmaceuticals Corporation. Thomas:Novartis Pharmaceuticals Corporation: Employment. Eldjerou:Novartis Pharmaceuticals Corporation: Employment, Equity Ownership.

Description: Introduction: Follicular lymphoma (FL) is the most common indolent non-Hodgkin lymphoma in the Western hemisphere. Patient characteristics and burden of FL are incomplete and vary from previous studies. This study evaluated patient profile, including patient characteristics, treatment patterns, and duration using real-world data. Methods: Using the Truven MarketScan® databases, patients with FL who were newly initiated with FL indicated regimens were identified from 1/1/2010-12/31/2013 (initial treatment identification period). Patients were selected if they were ≥18 years old, had 1 FL ICD-9 code (202.0) as primary or secondary diagnosis, at least 1 FL commonly prescribed systemic anti-cancer therapy after the diagnosis, and did not use any FL indicated regimen in the past 6 months prior to first agent included in the initial treatment identification period. These patents were followed ≥3 months or to June 30, 2018. Primary outcomes were the distribution of regimens by line, the number of patients who switched from first- to second-line therapies, and from second- to third-line therapies. The treatment duration by line of therapy and regimen were also analyzed. Discontinuation was defined as 3 months without receiving a regimen after treatment. Results: This study identified 4,970 patients who initiated treatment for FL. Of these patients, 48.1% were female (n=2,390), with a mean age of 62.0 (SD: 14.0) years. The average follow-up time was approximately 2 years (median: 733 days). In this analysis, 4,970 patients with FL received first-line therapy for 153 days (median: 94 days), 1,985 received second-line therapy (39.9% of patients who received first-line therapy) for 208 days (median: 80 days), and 664 received third-line therapy (13.4% of patients who received first-line therapy) for 117 days (median: 43 days). Of the 4,970 patients on first-line therapy, 453 (9.1%) remained on first-line therapy, 2,532 (51.0%) discontinued treatment, and 1,985 (39.9%) patients switched to the next line of therapy during the follow-up period. Of the 1,985 patients who switched to second-line therapy, 328 (16.5%) remained by the end of follow-up period, 993 (50.0%) discontinued, and 664 (33.4%) switched to the next line of therapy during the follow-up period. Of the 664 patients who switched to third-line therapy, 125 (18.8%) remained, 269 (40.5%) discontinued, and 270 (40.7%) switched to the next line of therapy. The most common first-line regimens in descending order received by patients were rituximab (n=1,478, 29.7%), R-CHOP (n=1,368, 27.5%), BR (n=1,050, 21.1%), R-CVP (n=371, 7.5%), and FCR (n=63, 1.3%). Second-line treatment regimens were (N=1,985) rituximab (n=992, 50.0%), BR (n=202, 10.2%), R-CHOP (n=138, 7.0%), and R-CVP (n=120, 6.1%). Third-line treatment regimens were (N=664) rituximab (n=228, 34.3%), BR (n=91, 13.7%), R-CHOP (n=75, 11.3%), cyclophosphamide (n=35, 5.3%) and R-CVP (n=31, 4.7%). Conclusion: This data set describes the percentage of patients that transition from first- to second-line and second- to third-line treatment for FL. The primary regimens used across the treatment lines conform to those recommended by the NCCN guidelines. In addition, smaller numbers of non-recommended regimens were reported. Disclosures Fowler: Celgene: Membership on an entity's Board of Directors or advisory committees, Research Funding; TG Therapeutics: Membership on an entity's Board of Directors or advisory committees, Research Funding; ABBVIE: Membership on an entity's Board of Directors or advisory committees, Research Funding; Janssen: Membership on an entity's Board of Directors or advisory committees, Research Funding; Novartis Pharmaceuticals Corporation: Consultancy; Roche: Membership on an entity's Board of Directors or advisory committees, Research Funding. Hao:Novartis Pharmaceuticals Corporation: Employment, Equity Ownership. Lim:Novartis Pharmaceuticals Corporation: Employment. Chen:Novartis Pharmaceuticals Corporation: Consultancy, Employment. Li:Novartis Pharmaceuticals Corporation: Employment. Arcona:Novartis Pharmaceuticals Corporation: Employment.